Over the years a wide variety of devices and methods have been developed to assist the health care practitioner in delivering medications, taking of body fluids and connecting medical devices. In more recent times, such devices and methods have been developed to not only assist the health care practitioner, but to also protect the health care practitioner and patients from needle sticks. Many of these devices and methods were also developed to work in a multifunctional manner with many different types of additional devices. Thus, a need remains for valve devices that may be used in fluid or gas flow and the transfer of fluids from medicinal containers, vials, bags and tubing to ports in other administrative structures for medical purposes.
Aside from the hazards of needle sticks from normal needle syringe transfers from medicinal vials to ports, there exists a common problem of reversal of fluid flow. Such a reversal of liquid flow through tubing occurs due to back pressure or leakage of the valves when used with medicinal containers such as a bottles or vials. The luer-type needle free valve device for fluid transfer, however, is able to accomplish these procedures to enable a health care professionals trained in formulation and performing patient care to obtain the necessary quantity of volumes in an uncontaminated state from a manufacturer's container, to then transfer a quantity of fluid or gas to a port without the use of needles or the hazard or danger of leakage from the device valve in either direction, i.e. leakage of the fluid from the port on either side of the valve due to back pressure or leakage of medicinal fluid from the vial, bottle or syringe.
Earlier types of valve devices used multiple purpose adapters having a valve positioned in the closed position by a spring. The spring in these devices was overridden by insertion of a needleless syringe tip against the valve, overcoming the spring load thus opening the valve. These valves can then be used to push fluids or gases into port systems such as bottles, vials, bags and tubing to act as a channel between the port systems and needleless syringe for obtaining the fluids or gases from the system. The needle-free valve device can be opened and closed to inject or withdraw fluids or gases. Such valve devices accommodate various uses in supplier containers and hospital settings.
Embodiments of luer-type needle-free valves are those where the valves can be opened using a needleless syringe, tubing or device. Syringes, tubing and devices such as these have had the needle removed so that the interfacing end has only the luer taper or luer lock. Typically, the state of the art in needle-free valves are known as Luer-Activated Devices. Embodiments of the Luer-Activated Device may control a valve that prevents the outflow of fluid or gas through the connector until a standard luer connector is inserted, allowing the valve to open and fluid or gases to be inserted or withdrawn. Three types of Luer-Activated Devices are known in the art. The first of these are capped Luer-Activated Devices requiring a cap to be attached to the valve when the valve is not in use. These types of devices are difficult to maintain aseptically because contamination can easily occur during manipulation, and the open luer connection is difficult to swab. The second type of Luer-Activated Device is the Capless Luer-Activated Device. Such devices don't require capping between uses and use positive-pressure to open and close the valve when attaching and disconnecting the valve. The third type of Luer-Activated Device is a positive fluid displacement Luer-Activated Device that is similar to the Capless Luer-Activated Device in the means by which they are used, except that they may expel fluid or gas when they are disconnected.
Each of the aforementioned devices suffer numerous disadvantages. For example, they consist of a valve fitting that is normally closed when not attached to a syringe. However, when a syringe is attached to the valve, it displaces a diaphragm plunger that opens the valve enabling the syringe to deliver liquids, gases or other flowable materials to the volume connected to the valve fitting outlet. One of the limitations of these devices is that the valve fitting is in a closed configuration during manufacturing, sterilization and packaging. Thus, if the outlet of the valve fitting were connected to a sealed volume such as a syringe, it would present a sterilization problem because sterilization agents would not have reached all surface areas of the valve fitting during the sterilization procedure before or after packaging. In addition, in pressurized sterilization systems, a valve fitting attached to a syringe would compound sterilization problems or other situations where atmospheric pressure differs internally and externally resulting in damage to the valve. The differences in pressure occurring when the volume connected to the valve fitting outlet and/or nearby structures expands or contracts. Such damage only being discovered at the point of use.
Needle-free valves are also typically used in manufacturing sterile medical devices. Such medical devices use luer valves to hermetically connect two volumes. A common application is the connection between vials, bottles, bags, tubing, needles, and syringes. During manufacturing of such devices it is often necessary for the outlet and inlet of a valve fitting to communicate so that fluid sterilizing agents reach all surfaces of the device and the volumes they connect. Often times such sterilization procedures are aided by placing the device in a vacuum chamber to assist in drawing fluid sterilization agents into the device through the valve. When used in this manner, the configuration of a luer type device in clinical use differs because it is common for the outlet and inlet to be held closed, thus permitting the user to develop a differential pressure between the volumes at the outlet and the inlet. In view of this, it is evident that a manufacturer's interests to maintain the valve in an open position does not coincide with the clinician's interests to maintain the valve in a closed position. For example, when the manufacturer attempts to sterilize a closed valve device with a gaseous sterilizing agent, the agent does not reach all of the surfaces of the device. And any vacuum environment used in the sterilizing environment will cause an undesired expansion of the volume connected to the fitting outlet, which may ultimately result in the connected volume rupturing and the end user receiving a non-sterile product that may be damaged. In addition, this undesired expansion of the connected volume may damage the product packaging thereby voiding the sterile barrier.
As discussed above, no device exists in the state of the art that compensates for this problem. The present invention solves these and other possible problems of conventional devices, and relates to a luer-type needle free valve device or adapter for use with fluid or gaseous flow and administration structures for medical purposes.
Further, the present invention provides a device that fulfills both the manufacturer's interests as well as the clinician's interests by providing a self contained valve that acts both as a normally open valve during sterilization and normally closed valve during use.